Glossary

EU MDR

THE EUROPEAN MEDICAL DEVICES REGULATION (EU MDR) IS A LEGAL DOCUMENT WHICH ESTABLISHES QUALITY REGULATIONS THAT MEDICAL DEVICE MANUFACTURERS MUST COMPLY WITH TO SELL THEIR DEVICES IN EUROPE.

On May 25th, 2016, a new legal mandate called the EU MDR was enacted to govern the quality requirements of medical devices for sale in the European Economic Area (EEA). The EU MDR replaces both the Medical Devices Directive (93/42/EEC) and the Active Implantable Medical Devices Directive (90/385/EEC) and allows medical device manufacturers a three-year transition period to establish compliance with the new requirements. With a newly revised edition of the EU MDR released at the beginning of 2017, the roll-out of the new requirements is expected to be completed by 2020 for medical devices and by 2022 for in vitro medical devices.

NEW EU MDR AFFECTS ALL CURRENTLY CERTIFIED DEVICES

With some exemptions currently under negotiation, the general requirement under the new MDR is that all currently approved devices must be re-certified to ensure their compliance with the new medical device requirements. Even medical devices that obtained CE markings under the previous regulations must demonstrate compliance with the new EU MDR.

Additionally, manufacturers of Class IIa and IIb medical devices will need to review their existing clinical evaluations to determine whether they satisfy the updated regulations. Certain medical devices that were previously exempt from requiring clinical evaluations may now require them.

MANUFACTURER'S FACE EXPANDED POST-MARKET SURVEILLANCE IN EUROPE

One of the objectives for revising the EU MDR was to expand post-market surveillance of medical devices in Europe. The European Commission designates Notified Bodies to oversee compliance certification and CE markings in Europe, and under the new MDR, these organizations will have the power to conduct unannounced audits, including product testing and product sample checks.

Some medical device manufacturers will be required to produce annual safety and performance reports pertaining to the products they sell in the European marketplace.

To add an additional layer of safety for consumers, the EU MDR also mandates unique device identification (UDI) for all medical devices sold in the continent, ensuring that authorities can efficiently trace devices through the supply chains and initiate prompt and targeted recalls when required.

PRODUCTS NEWLY AFFECTED BY EU MDR

Some products that were not covered under the previous Medical Devices Directive (MDD) will be covered by the new EU MDR. Annex XVI of the MDR describes six categories of devices newly covered by this legislation:

Contact lenses, or other items that go into the eye.

Products that are introduced surgically to modify the anatomy.

Substances or items used for facial filling by subcutaneous or intradermal injection.

High-intensity electromagnetic radiation emitting equipment for use on the human body, like for tattoo or hair removal.

Equipment that uses electrical currents of electromagnetic fields to penetrate the cranium to modify neuronal activity in the brain

GREENLIGHT GURU’S EQMS SOFTWARE HELPS YOU COMPLY WITH EU MDR

Whether you manufacture a product that is newly covered under the EU MDR, a medical device that was certified under the MDD, or you're building a new medical device for the first time, the EU MDR requires you to establish and maintain a quality management system.